Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

NCT00462124 | Completed Results

• 1 other identifier: BP-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events. Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.

Conditions

Prostate Cancer

Keywords

Prostate; cancer; radiation; biodegradable implantable balloon; intrarectal balloon

Outcome Measures

Primary Outcomes (1)

• Safety of Balloon Implant

  Assessed by collecting number of subjects experiencing a serious device related adverse event.

  6 months

Secondary Outcomes (1)

• Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum

  6 months

Study Arms (1)

Balloon

OTHER

Implantation of a biodegradable balloon spacer (absorbable perirectal spacer)

Device: Absorbable perirectal spacer

Interventions

Absorbable perirectal spacer DEVICE

biodegradable balloon implant to increase the distance between prostate and anterior rectal wall

Balloon

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged ≤80.
• Men with child producing potential (that are not sterile) must accept using adequate contraceptive throughout the radiotherapy phase and for at least 3 months after completion of the radiotherapy phase when ever they have heterosexual intercourse.
• Diagnosed prostate cancer not spread outside the capsule (T1 and T2).
• Subject is scheduled for localized prostate XRT treatments.
• Zubrod performance status 0-1; or Karnofsy \>80.
• Pre-randomization serum PSA lower than 25 (obtained prior to any LHRH or antiandrogen therapy); or Kattan nomogram less than 15 %.
• Subject able to comprehend and give informed consent for participation in this study.
• Probability of lymph node involvement based on Kattan nomogram less than 15 %.
• Normal blood CBC and biochemistry up to two weeks before screening as follow:
• Normal CBC
• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 10.0 g/dl
• Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
• Adequate liver function, with serum bilirubin \< 2.0 mg/dl

You may not qualify if:

• Prior radical prostatectomy, cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer.
• Prior radiotherapy to the pelvis, including brachytherapy at the same body organ.
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
• Transmural myocardial infarction within the last 6 months prior to screening.
• Acute infection requiring intravenous antibiotics at the time of screening.
• Bleeding disorders.
• Uncontrolled diabetes mellitus
• HIV positive or any other immunosuppressive disorder.
• Renal failure (Serum creatinine \>2.0 mg/dl).
• Inflammatory diseases of the perineal skin.
• Urinary tract infection or acute or chronic prostatitis.
• Active inflammatory bowel disease.
• Rectal carcinoma.
• Subjects after anterior resection of rectum or after rectal amputation.
• Known cognitive disorder.

Sponsors & Collaborators

• BioProtect: lead

Study Sites (1)

Ichilov Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

This was an initial human experience feasibility study.

Results Point of Contact

• Title: Galit Itzhaki
• Organization: BioProtect

galit@bioprotect.co.il

+972-9-7731929

Study Officials

• Yossi Muncher, Dr.

  BioProtect

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2018-02

Locations

IL (1)